Auxiliary medicinal product means a medicinal product used for the needs of a clinical trial as described in the protocol, but not as an investigational medicinal product.
Auxiliary medicinal products (AxMP) are medicinal products used in the context of a clinical trial as described in the protocol for background treatments, as challenging agents, rescue medication or to assess the end-points. See also the document on auxiliary medicinal products in clinical trials.
Examples are medicinal products used as rescue medication, challenge agents, to assess end-points in the clinical trial, or background treatment. Further, the medicinal product should be related to and relevant for the design of the clinical trial, which excludes ‘concomitant medications’.
In principle, only authorised medicinal products should be used as AxMP in clinical trials (article 59 of the CTR). However, in certain circumstances unauthorised auxiliary medicinal products may be used, for instance an authorised AxMP is not available in the EU or where the sponsor cannot reasonably be expected to use an authorised AxMP. This has to be justified in the protocol.
Where the AxMP is not authorised, or where an authorised AxMP is modified while such modification is not covered by a marketing authorisation, it shall be manufactured according to GMP requirements or to at least an equivalent standard, in order to ensure appropriate quality. The documentation requirements in the application dossier for IMPs also apply to unauthorised AxMPs.
Please note: authorised unmodified AxMP only need to be listed in the cover letter, it is not necessary to enter these products in CTIS and submit an SmPC.